Contemporary Clinical Trials[JOURNAL]
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200 papers
Trials augmented by external control data using balancing weights: A comparison of estimands and estimators.
Wang P, Hong H, Jeon K … +1 more , Thomas LE
Contemp Clin Trials · 2026 Mar · PMID 41539535 · Publisher ↗
As the availability of real-world data has expanded in recent years, studies leveraging external controls (ECs) have emerged as potential alternatives to conventional randomized controlled trials (RCTs). While RCTs remai...
As the availability of real-world data has expanded in recent years, studies leveraging external controls (ECs) have emerged as potential alternatives to conventional randomized controlled trials (RCTs). While RCTs remain the gold standard for estimating treatment effects, in some contexts, such as rare diseases, it is infeasible or unethical to enroll and randomize a sufficient number of patients. In such cases, it may be justified to conduct a hybrid or single-arm trial that incorporates EC data. This integration first depends on the harmonization of inclusion criteria, covariates, and outcomes, and then requires appropriate statistical methods that account for differences between the trial and EC patients. The propensity score (PS) has emerged as a valuable tool to summarize such differences in patient characteristics. The PS may contribute to a range of estimation methods, including balancing weights, augmented estimators, and Bayesian methods for dynamic borrowing. However, in the context of trials with ECs, the interpretation of the PS and associated causal estimands is often unclear. Motivated by the LIMIT-JIA trial of juvenile idiopathic arthritis, we elucidate potential estimands and evaluate the performance of PS-weighted estimators. We show that some estimands are easier to estimate than others, with potentially greater feasibility for small studies like LIMIT-JIA.
Quantifying the role of communication in recruitment status outcomes for a clinical trial on genetic testing uptake.
Morel A, Delacroix E, Rice JD … +6 more , Austin S, Koeppe E, Hanson EN, Griggs JJ, Stoffel EM, Resnicow K
Contemp Clin Trials · 2026 Feb · PMID 41520997 · Publisher ↗
BACKGROUND: Participant recruitment remains a significant challenge in clinical trials, often resulting in delays, increased resource expenditures, and missed opportunities for advancing care. While previous research has...
BACKGROUND: Participant recruitment remains a significant challenge in clinical trials, often resulting in delays, increased resource expenditures, and missed opportunities for advancing care. While previous research has largely focused on participants' perspectives regarding recruitment barriers, less is known about the influence of different outreach strategies (methods and frequency) from the viewpoint of research staff. This study evaluates the likelihood of reaching a definitive enrollment outcome to inform more effective and resource-efficient recruitment strategies. METHODS: Data were obtained from recruitment efforts for a two-phase clinical trial aimed at increasing hereditary cancer genetic testing uptake among eligible individuals. Participant recruitment utilized email invitations for patients in participating practices and multimedia campaigns for the public. Eligible participants received up to two email reminders and 5-8 recruitment calls, with a standardized call survey ensuring consistency. RESULTS: Of the invited, 2485 (82.8%) accessed the email link and completed the eligibility screening survey, of these 80.4% of invitees reached a definitive recruitment status outcome: ineligible (37.2%), refused (15.6%), consented (27.6%), while 19.5% were lost to enrollment. Analysis of call attempts revealed that call attempt one had the highest participant answer rate (∼45%), which declined with each additional attempt, reaching 13% at six or more attempts. Email outreach alone produced probability spikes in definitive outcomes following email reminders. Additional calls demonstrated sharply diminishing returns beyond the fourth to sixth attempts. CONCLUSION: This study demonstrates that tracking and optimizing outreach frequency, timing, and mode can enhance clinical trial recruitment efficiency. Specifically, at least one email and one phone call significantly improve the likelihood of reaching a definitive recruitment outcome, while exceeding 4-6 call attempts yields minimal additional benefit. These findings provide a framework for recruitment strategies, enabling more effective allocation of resources and increasing the chances of meeting recruitment goals in future clinical trials.
The long-term effectiveness of the anti-obesity medication phentermine (LEAP) trial: Rationale, design, and baseline characteristics.
Young CB, Rives E, Gudzune KA … +15 more , Jaeger BC, Simmons CG, White BN, Hooker SA, Horn DB, Young DR, Vesely J, Velazquez A, Price C, Cook SD, Martin-Fernandez K, Inzhakova G, Pajewski NM, Ard JD, Lewis KH
Contemp Clin Trials · 2026 Feb · PMID 41519431 · Full text
BACKGROUND: Current clinical practice guidelines support the long-term use of pharmacotherapy for obesity treatment. Historically, phentermine has been one of the most prescribed obesity medications (OMs), however, its l...
BACKGROUND: Current clinical practice guidelines support the long-term use of pharmacotherapy for obesity treatment. Historically, phentermine has been one of the most prescribed obesity medications (OMs), however, its long-term efficacy and safety have never been evaluated in a randomized trial as its market approval predates such requirements. Here we describe the design, rationale, and baseline characteristics for a 24-month, double-blind, randomized controlled trial evaluating the efficacy, cardiovascular risk, and safety of phentermine in adults with overweight or obesity. METHODS: This multicenter trial will compare outcomes among participants randomized to phentermine 24 mg daily versus placebo for 24 months. All participants also receive an online lifestyle intervention. A total of 870 participants with body mass index of 27-44.9 kg/m were randomized across six sites in North Carolina (2), Minnesota, Texas, and California (2). Primary outcomes are 24-month mean percent weight loss (efficacy), 24-month mean change in systolic blood pressure (cardiometabolic risk), and overall rates of adverse events and serious adverse events (safety). Secondary outcomes include changes in resting energy expenditure/resting metabolic rate, cardiac autonomic function measured using heart rate variability with electrocardiogram, and a self-reported measure of phentermine dependence. CONCLUSIONS: The safety and efficacy of long-term phentermine remains a pressing, unanswered question, particularly given its low cost and high availability when compared to newer OMs that are highly effective but often associated with significant costs. This study will impact clinical practice regardless of result - either providing evidence to support use of an available low-cost option or prioritizing the use of other OMs. TRIAL REGISTRATION: Clinicaltrials.gov, NCT05176626.
Trial design and enrolment characteristics of LATA (Long-Acting Treatment in Adolescents): A randomised, open-label, non-inferiority, 96-week trial evaluating the virological efficacy, safety, acceptability and quality-of-life of the dual long-acting injectable regimen cabotegravir/ rilpivirine compared to daily oral therapy in virologically suppressed adolescents with HIV-1 infection, aged 12 to <20 years, in Sub-Saharan Africa.
Anena D, Chappell E, Nazzinda R … +26 more , Kiilu C, Chitsamatanga M, Arumugam T, Green A, Kityo Mutuluuza C, Bwakura-Dangarembizi M, Siika A, Archary M, Jafta L, Namukwaya S, Seeley J, Akabwai G, Mugerwa H, Bevers L, Burger D, Walker S, Bamford A, South A, Apoto N, Bush M, Thomason MJ, Spittle B, Ford D, Kekitiinwa AR, Pett SL, LATA Trial Team
Contemp Clin Trials · 2026 Mar · PMID 41512916 · Publisher ↗
BACKGROUND: Alternatives to daily oral antiretroviral therapy (ART) are important for adolescents with HIV (AHIV) to improve adherence and outcomes. Long-Acting-injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) has dem...
BACKGROUND: Alternatives to daily oral antiretroviral therapy (ART) are important for adolescents with HIV (AHIV) to improve adherence and outcomes. Long-Acting-injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) has demonstrated excellent efficacy and safety and strong patient preference in adults. METHODS: LATA is an ongoing randomised, open-label, 96-week, non-inferiority trial evaluating the efficacy, safety and acceptability of LAI CAB/RPV vs. daily oral therapy with tenofovir (disoproxil fumarate or alafenamide)/lamivudine/dolutegravir (TLD). Participants are virologically suppressed AHIV aged 12- < 20 years in Kenya/South Africa/Uganda/Zimbabwe. Randomisation was 1:1 to LAI CAB/RPV given once every 8 weeks (after optional oral lead-in) or daily oral TLD. The primary outcome is viral rebound (two consecutive viral loads ≥50 copies/mL by 96-weeks). Viral loads are measured every 24 weeks. The trial employs the Smooth Away From the Expected (SAFE) non-inferiority frontier, where the non-inferiority margin depends on the observed event rate in the control arm. Secondary outcomes include confirmed viral load ≥200 copies/mL by 96-weeks, HIV resistance, safety, patient-reported outcomes and cost-effectiveness. LAI participants return to oral ART at confirmed viral load ≥200 copies/mL; LAI participants who become pregnant are given the choice to continue on LAI or to switch back to daily oral ART, with optional pharmacokinetic sampling during pregnancy and post-partum in both groups. Enrolment of 476 AHIV completed in April 2024. Results will be reported in 2026. CONCLUSION: LATA is the first trial comparing the efficacy, safety and acceptability of LAI CAB/RPV to oral ART in AHIV, enrolled in Sub-Saharan Africa, using a programmatic approach to viral load testing. TRIAL REGISTRATION: This trial has been registered with ClinicalTrials.gov (NCT05154747).
Stand up for your health: Rationale and design for a randomized controlled trial.
Hammad M, Shankar S, Gao Y … +1 more , Kulinski J
Contemp Clin Trials · 2026 Feb · PMID 41506470 · Full text
BACKGROUND: Sedentary behavior is an independent risk factor for cardiometabolic disease. With the rise of desk-based occupations and work-from-home culture, the workplace offers a promising setting to employ interventio...
BACKGROUND: Sedentary behavior is an independent risk factor for cardiometabolic disease. With the rise of desk-based occupations and work-from-home culture, the workplace offers a promising setting to employ interventions to reduce sedentary time. OBJECTIVE: The goal of this randomized controlled trial is to determine if reducing sedentary time with sit-stand desks improves cardiometabolic health outcomes in overweight and obese individuals with sedentary jobs who are at risk of developing diabetes. METHODS: Approximately 198 eligible participants (includes estimated 25% drop-out) with pre-diabetes or at-risk for type 2 diabetes will be randomized in a 1:1:1 ratio into three groups: a control group (no intervention), a 2-h group (instructed to stand at their sit-stand desks for at least 2 h daily), and a 3-h group (instructed to stand for at least 3 h daily). Each participant will complete three study visits over a 6-month period. The primary outcome is insulin resistance. DISCUSSION: The potential impact of this study is significant, given that over 70% of the U.S. population is overweight or obese, and more than 80% of jobs are sedentary. Affirmative findings from our study would advance the field by demonstrating that an easily adoptable intervention can reduce cardiometabolic risk, providing justification for widespread implementation of standing desks in the workplace. CONCLUSION: This randomized, control study will determine if reducing sedentary behavior at work, with an adjustable sit-stand desk, improves insulin resistance in individuals at risk for diabetes. This study may help inform public health guidelines benefitting a large population of sedentary workers. Clinical trial registration identifier: NCT05585190.
Rationale, design, and protocol for a sequential, multiple assignment, randomized trial of adaptive treatment for smoking cessation: The ADAPT trial.
Brown GA, McCamy WC, King DI … +6 more , Ferreira AC, Wahlquist AE, Kaczmar J, Cropsey KL, Carpenter MJ, Smith TT
Contemp Clin Trials · 2026 Mar · PMID 41500497 · Full text
BACKGROUND: Most attempts to quit smoking cigarettes end in failure, even when FDA-approved pharmacotherapies are used. Despite the frequency of treatment non-response, few trials have investigated the best path forward...
BACKGROUND: Most attempts to quit smoking cigarettes end in failure, even when FDA-approved pharmacotherapies are used. Despite the frequency of treatment non-response, few trials have investigated the best path forward after treatment failure. This trial will assess two primary aims: 1) determine whether switching pharmacotherapies following initial failure promotes abstinence more effectively than repeated attempts with the same pharmacotherapy, and 2) determine whether switching to e-cigarettes following successive failures with pharmacotherapy promotes abstinence from combustible cigarettes better than continuing with pharmacotherapy. METHODS: Adults in South Carolina and Alabama who smoke daily and are willing to set a quit date will be assigned in a counterbalanced fashion to receive a 4-week supply of FDA approved smoking-cessation medication (either combination nicotine replacement therapy or varenicline) and asked to set a quit date. After four weeks of treatment, treatment non-responders will be assigned in a 2:1 fashion to either switch medications or continue with the same medication (Aim 1). After a second four weeks of treatment, non-responders will be assigned in a 2:1 fashion to either switch to e-cigarettes or continue with the same pharmacotherapy (Aim 2), with outcomes assessed through 6 months (Aim 3). The primary outcome is biochemically confirmed 7-day abstinence from smoking, assessed repeatedly across separate study aims. Secondary outcomes include smoking reduction, nicotine dependence, and duration of abstinence. CONCLUSION: This trial is positioned to provide strong, data-driven guidance on treatment decision-making following treatment failure. The trial results will provide a significant opportunity to optimize cessation outcomes for people who smoke and continue to struggle with quitting.
Enhancing effect of cognitive control training on rTMS treatment in depression: A study protocol for a multicenter randomized controlled trial.
Dalhuisen I, Wurkum M, Bervoets C … +10 more , Constant E, van Exel E, Hiligsmann M, Sack AT, Schuhmann T, Tendolkar I, Verplancke T, Wijnen B, Baeken C, van Eijndhoven P
Contemp Clin Trials · 2026 Feb · PMID 41490772 · Publisher ↗
INTRODUCTION: Repetitive transcranial magnetic stimulation (rTMS) is an effective treatment for major depressive disorder (MDD), yet some patients only show partial or no response. Recent efforts to enhance rTMS efficacy...
INTRODUCTION: Repetitive transcranial magnetic stimulation (rTMS) is an effective treatment for major depressive disorder (MDD), yet some patients only show partial or no response. Recent efforts to enhance rTMS efficacy have focused on combining rTMS with adjunctive interventions, such as psychotherapy, which may yield synergistic effects rather than merely additive effects. Cognitive control training (CCT) activates similar underlying neural circuits as rTMS and has demonstrated antidepressant potential. Given the time-intensive nature of rTMS, augmenting it with CCT may offer a pragmatic, time-efficient and potentially cost-effective solution to increase the therapeutic response of rTMS. This study aims to investigate whether rTMS augmented with CCT is more (cost-) effective in reducing depressive symptoms as opposed to rTMS alone. METHODS: In this international multicenter clinical trial, 132 adult patients with depression will be randomized to receive rTMS either augmented with CCT or placebo task. The trial consists 30 rTMS sessions over eight weeks, followed by a follow-up period up to one year. The primary outcome is the change in depressive severity, assessed with the 17-item Hamilton Depression Rating Scale (HDRS-17) after eight weeks of treatment. Secondary outcomes include an economic evaluation and response and remission after 8 weeks of treatment as well as during follow-up. DISCUSSION: The present study aims to improve the (cost-)effectiveness of rTMS by concurrently combining rTMS with CCT. Findings may support the development of more cost-effective, personalized interventions for the treatment of depression. TRIAL REGISTRATION: This trial is registered within the Overview of medical research in the Netherlands, OMON (code: NL-OMON57187, date: 18 December 2024).
Testing the effects of a text message intervention on depression and distress among Latino dementia caregivers: A randomized controlled trial protocol.
Perales-Puchalt J, Ramírez-Mantilla M, Moore HP … +16 more , Velez-Uribe I, Sepulveda-Rivera V, Ruiz R, Fracachán-Cabrera M, Herrera Y, Baker C, Miras-Neira A, Bothwell B, Anderson H, Lewandowski T, Diaz FJ, Greiner KA, Williams K, Vidoni ED, Ellerbeck E, Burns JM
Contemp Clin Trials · 2026 Feb · PMID 41485525 · Full text
BACKGROUND: Latino caregivers have poor mental health and access to caregiver support services. Here, we describe the protocol for a randomized controlled trial (RCT) to evaluate the effect of a text message intervention...
BACKGROUND: Latino caregivers have poor mental health and access to caregiver support services. Here, we describe the protocol for a randomized controlled trial (RCT) to evaluate the effect of a text message intervention on depression and distress among informal Latino dementia caregivers. We will also assess mechanisms of action. METHODS: We are enrolling 288 Latino dementia informal caregivers 18 or older into a parallel group RCT. Participants randomized to the intervention group receive a remote, asynchronous, bilingual, bi-directional, 6-month texting program focused on dementia education, skill-building and community resources. The control group enters a 7-month waitlist after which they are offered the same intervention as the intervention group. Randomization is stratified by each of the four recruitment sites at a 1:1 ratio. Outcomes (e.g., caregiver depressive symptomatology, distress) are measured via surveys at baseline, 3, 6 and 7 months. CONCLUSIONS: This RCT addresses two priority areas: eliminating dementia disparities and optimizing caregiver support. Findings have the potential to make clinical and policy-relevant contributions by providing appropriate caregiver support to Latinos in a highly scalable way. Protocol version/date: 1/14/2025.
50k4Life: A SMART study protocol to improve walking engagement in public school employees on the US-Mexico border.
Salinas JJ, Buchholz SW, Yin Z … +8 more , Gay JL, Wang J, Rajbhandari-Thapa J, Wilson MG, Finley E, Mulla Z, Ramirez E, Medina DP
Contemp Clin Trials · 2026 Feb · PMID 41485524 · Full text
INTRODUCTION: Mexican Americans living in the U.S.-Mexico border region suffer disproportionately from preventable cardiometabolic and cancer diseases. Workplace health promotion programs that include physical activity p...
INTRODUCTION: Mexican Americans living in the U.S.-Mexico border region suffer disproportionately from preventable cardiometabolic and cancer diseases. Workplace health promotion programs that include physical activity promotion are promising strategies to address this public health problem to improve physical activity engagement. Workplace-based programs can increase moderate to vigorous physical activity (MVPA) engagement while addressing barriers associated with inactivity. METHODS: We plan to conduct a clustered Sequential Multiple Assignment Randomized Trial (SMART) to determine the effectiveness of a workplace walking challenge intervention - 50,000 for Life (50K4Life) - in improving brisk walking engagement (at least 7000 steps/day, representing approximately 50,000 steps/week) for public school employees. The two-phase trial will include 30 public schools in two cohorts (15 per cohort) with predominantly Mexican American employees from El Paso County area schools in Texas on the U.S.-Mexico border. In Phase 1, the schools will be randomly assigned to 50K4Life or 50K4Life plus app-based push notifications. In Phase 2, schools with 50 % or more participants accumulating 50,000 steps/week will continue receiving the same intervention. The remaining schools will be randomly assigned to receive individual or school-level intervention. As part of our intervention evaluation, we will conduct a process and cost-effectiveness evaluation to provide insight into cost and scalability. DISCUSSION: This study will provide evidence to support the implementation of walking challenge-based interventions that improve engagement among Mexican Americans living in the U.S.-Mexico border region.
Kinesiologist-delivered mobilization to mitigate inpatient frailty: A study protocol for a randomized controlled trial.
Shivgulam ME, Dumont M, Ahmadi S … +6 more , Courish M, Barrieau L, Cormier L, Theou O, Mekari S, O'Brien MW
Contemp Clin Trials · 2026 Feb · PMID 41453522 · Publisher ↗
BACKGROUND: Hospitalized older adults spend excessive amounts of time in sedentary postures (sitting/lying while awake). Mobilizing patients may prevent physical deconditioning, exacerbated frailty levels, and worsened h...
BACKGROUND: Hospitalized older adults spend excessive amounts of time in sedentary postures (sitting/lying while awake). Mobilizing patients may prevent physical deconditioning, exacerbated frailty levels, and worsened hospital outcomes. The purpose of this study will be to test the hypothesis that compared to usual care, patients who receive multiple kinesiologist visits each day will, 1) increase their step counts and upright time, 2) decrease their frailty levels from admission to discharge, and 3) have shorter lengths of stays and decreased readmission rates. METHODS: Sixty middle-aged-to-older adult patients (≥50 years) from a general/internal medicine unit will be randomized into a usual care control (visit from the kinesiologist once/day) or intervention group (multiple visits from the kinesiologist/day). Kinesiologist visits will include individualized patient mobilization. All participants will be equipped with three waterproofed activPAL inclinometers positioned on their thigh, torso, and shin for 24-h/day throughout hospitalization to measure physical activity (step counts, physical activity intensity), upright postures, and detailed sedentary postures (bent-legged sitting, straight-legged sitting, lying). Frailty will be assessed via a validated 65-item index and the Clinical Frailty Scale two weeks before admission (retrospectively), at admission, and at discharge. Secondary measures will include length of stay and hospital re-admissions. Mixed models for repeated measures will determine whether daily activity differed between groups, changed throughout hospital stay, and effected frailty levels. DISCUSSION: This randomized controlled trial will aim to refine mobilization strategies and individualize interventions for the prevention of decline in mobility and worsening frailty among hospitalized patients. TRIAL REGISTRATION: The protocol has been registered at clinicaltrials.gov (identifier: NCT06802289).
The influence of peer navigators on intervention adherence and retention among older adults: A study within a randomized trial - SWAT.
Runge SK, Hudak EM, Sutfin JA … +2 more , Dobrovolskiy VR, Edwards JD
Contemp Clin Trials · 2026 Feb · PMID 41453521 · Full text
BACKGROUND/PURPOSE: Participant engagement such as intervention adherence and study retention are critical to evaluating treatment efficacy and clinical trial success. Investigations of navigators among patients with chr...
BACKGROUND/PURPOSE: Participant engagement such as intervention adherence and study retention are critical to evaluating treatment efficacy and clinical trial success. Investigations of navigators among patients with chronic illness report improved health-related outcomes; however, little is known about the effects of navigators in healthy populations or on participant engagement in clinical trials. The purpose of this study was to explore whether peer navigators - former study participants - enhanced intervention adherence or study retention in a clinical trial among healthy older adults. METHODS: We conducted a study within a randomized clinical trial (SWAT) among community-dwelling older adults (N = 268) by assigning a subsample of participants to peer navigators (n = 36). Six former trial participants served as peer navigators. Statistical analyses explored whether navigator assignment was associated with intervention adherence or study retention. RESULTS: Participants assigned to a navigator were not different from the overall trial sample and were, on average, 71 years of age (SD = 5) with 16 years of education (SD = 3); 56 % identified as female, 81 % as White, and 3 % as Hispanic. Navigator assignment was associated with better intervention adherence, t(134.2) = -6.0, p < .001; participants with a navigator completed an average of 5 more sessions (M = 20, SD = 3) compared to those without a navigator (M = 15, SD = 8). Retention was higher among navigator-assigned participants (100 % vs. 76 %), X (1, N = 261) = 10.0, p = .002. CONCLUSIONS: Peer navigators may improve intervention adherence and study retention among older adults in clinical trials. Results suggest that personalized support by a peer may enhance participant engagement in clinical trials, but replication is needed. The data are from the registered clinical trial: Interventions to Attenuate Cognitive Decline, https://clinicaltrials.gov/study/NCT03528486.
Study design and methodologies for the men moving forward lifestyle intervention trial with black prostate cancer survivors.
Awoyinka I, Sheean P, Papanek P … +6 more , Flynn KE, Bylow K, Kilari D, Gann P, Banerjee A, Stolley M
Contemp Clin Trials · 2026 Feb · PMID 41453520 · Full text
BACKGOUND: Prostate cancer (PC) incidence and mortality rates are significantly higher among Black/African-American (Black) men compared to men of other race/ethnicities. Comorbidities and compromised quality of life are...
BACKGOUND: Prostate cancer (PC) incidence and mortality rates are significantly higher among Black/African-American (Black) men compared to men of other race/ethnicities. Comorbidities and compromised quality of life are also greater challenges for this community of men. Many factors drive these differences among which body composition and health behaviors are important, yet modifiable contributors. Lifestyle interventions report beneficial results for PC survivors; however, the inclusion of Black men is critically limited. This paper describes Men Moving Forward (MMF) -a community-based lifestyle intervention for Black men with PC. METHODS/DESIGN: This trial will randomize (1:1) 200 Black men with PC who completed treatment or are on active surveillance. The 16-week MMF intervention, conducted in partnership with the Milwaukee Recreation system, supports adoption of the American Cancer Society Nutrition and Physical Activity guidelines. Measures of body composition (primary), behavior (diet, physical activity), fitness, quality of life, and biomarkers of general health and PC recurrence risk are collected at baseline, post-intervention and at a 12-month follow-up. The primary hypothesis is that men receiving the MMF intervention will exhibit greater changes in body composition than those in the wait-list control group. DISCUSSION: The MMF trial addresses an important gap in the current literature, evaluating the potential efficacy of a lifestyle program developed with and for Black men with PC. Outcomes including body composition and biomarkers of general health and PC recurrence risk add to our knowledge and methodologies on health behaviors and PC survivorship. Study results will inform survivorship efforts for this high-risk, underrepresented population. U.S. CLINICALTRIALS: gov number: NCT03971591, 06.01.2019.
Pediatric asthma management via integration of a remote spirometry device into an EHR-based artificial intelligence-powered clinical decision support system: A feasibility pragmatic clinical trial.
Myers L, Brereton TA, Overgaard S … +29 more , Greenwood JD, Zheng L, Ohde JW, Spiten M, Kathy Ihrke RN, Lang K, Peterson K, Hawley S, Beenken M, Malik M, Bublitz J, Galloway T, Wilkes Q, Shrader D, Mercado L, Park M, Arteta M, Hartz M, Fladager-Muth J, Quam M, Perrigo T, Loufek T, Khurana A, Kshatriya BSA, Sharma D, Le-Rademacher J, Wi CI, Nordlund B, Juhn Y
Contemp Clin Trials · 2026 Feb · PMID 41453519 · Publisher ↗
BACKGROUND: Asthma is the most common chronic disease in children. Suboptimal asthma control is prevalent and causes significant health care costs. Electronic health records (EHRs) contain vast data which pose a major ch...
BACKGROUND: Asthma is the most common chronic disease in children. Suboptimal asthma control is prevalent and causes significant health care costs. Electronic health records (EHRs) contain vast data which pose a major challenge for timely and efficient access to relevant information for clinical decision making. To address this challenge, a machine learning and natural language processing models-powered clinical decision support system (CDS) called Asthma-Guidance Prediction System (A-GPS) was developed. A-GPS automatically extracts and synthesizes pertinent patient data from EHRs for asthma management. To further enhance A-GPS, real-time patient data was added from a home spirometry device and mobile app system (AsthmaTuner), that remotely collected patient-reported outcomes for asthma control and lung function and delivered a clinician-prescribed Asthma Action Plan from EHR to patients. The goal of the study was to assess the feasibility and satisfaction of implementation of an integrated A-GPS with AsthmaTuner for remote asthma management within pediatric primary care. METHODS: Study design was a parallel-group, non-blinded, dual-site, 2-arm pragmatic, randomized clinical trial (RCT) with 22 dyads (one clinician and one pediatric patient) at Mayo Clinic Health System and Mayo Clinic, Rochester, Minnesota. The primary endpoint was successful implementation of the integrated A-GPS with AsthmaTuner in primary care and study participants' satisfaction. CONCLUSION: The technological integration and application of the integrated A-GPS and AsthmaTuner in primary care as a clinical CDS for remote asthma management was feasible. This protocol provides developers with a framework for the best practices for evaluating AI tools and enables digital technology via an RCT. TRIAL REGISTRATION: Registered via ClinicalTrials.govNCT06062433 SIGNIFICANCE: We anticipate this study will establish a conceptual and operational framework for implementing AI-powered CDS in pediatric asthma management, with the goal that these methodological advancements will be expanded to the management of adults with asthma and other chronic complex diseases. Reporting a clinical trial protocol for the evaluation of an AI tool and following the reporting guidelines are valuable for establishing best practices evaluating AI tools, specifically for the developers and other key stakeholders who plan to evaluate AI models via RCTs in health care settings. We plan to communicate our trial results via publication and reporting in ClinicalTrials.gov database (NCT06062433). Authorship on publications will follow international standards for authorship (i.e., ICMJE).
Clinical trial coordination of multifaceted ethical and regulatory oversight entities during the COVID-19 public health emergency.
Gawad A, Mendoza J, Singleton M … +13 more , Majkowski R, Hopkins E, Carll J, MacInnis C, Amirault D, Jackson B, McBee N, Mould A, Eyzaguirre LM, Pessoa-Gingerich C, Shoham S, Sullivan D, Lane K
Contemp Clin Trials · 2026 Feb · PMID 41453518 · Full text
We implemented two outpatient randomized controlled trials of COVID-19 convalescent plasma during the COVID-19 public health crisis. Unique challenges included how to maneuver all the moving parts to precipitously mobili...
We implemented two outpatient randomized controlled trials of COVID-19 convalescent plasma during the COVID-19 public health crisis. Unique challenges included how to maneuver all the moving parts to precipitously mobilize and guide clinical teams and facilities through multiple review groups, to reach multiple target populations, and to share trial results. We describe how a flexible clinical trial coordinating center team approached and robustly coordinated multiple regulatory agencies and protocol changes to keep up with rapidly changing pandemic conditions and knowledge. Four agencies oversaw ethical and regulatory reviews for 26 participating sites, two protocols, and two master informed consent forms, in English and Spanish, through a two-month start-up cycle and 68 protocol and consent form changes, culminating in a national conversation of positive trial results presented in a public forum by the site investigators to trial participants. Ethical and regulatory reviews were at a faster than usual pace, sites were ready to activate in 12-15 days, and about 2 % of those transfused used Spanish language materials. Although these extraordinary practices cannot become standard, they can provide lessons for normal and emergency trial conduct. From a clinical trial coordinating center viewpoint, we recommend developing emergency interagency standard operating procedures (SOPs) for coordinating protocol reviews and emergency ceding guidelines among agencies when multiple regulatory reviews are required. English and non-English Informed Consent Forms (ICFs) developed centrally and in parallel and including a return of trial results to participants as a contact option should help trials improve participant-centered outreach.
STARRS-PC: A stepped approach to reducing suicide in primary care: Design and methods of a hybrid type 1 effectiveness-implementation trial.
Fontanella CA, Hughes JL, Brock G … +10 more , Ruch DA, Kemper AR, Bunger AC, Walker DM, McAlearney AS, Maa T, Miller M, Desirazu P, Obee J, Bridge JA
Contemp Clin Trials · 2026 Feb · PMID 41453517 · Full text
BACKGROUND: Suicide is the second leading cause of death among youth aged 12-17. Although most at-risk youth receive primary care, routine screening is limited in primary care due to provider discomfort, time constraints...
BACKGROUND: Suicide is the second leading cause of death among youth aged 12-17. Although most at-risk youth receive primary care, routine screening is limited in primary care due to provider discomfort, time constraints, limited training, and inadequate referral sources. Research evaluating and implementing suicide prevention strategies in pediatric primary care is vitally needed. PURPOSE: We aim to test the effectiveness of the Stepped Approach to Reducing Suicide in Primary Care (STARRS-PC), a population-based quality improvement intervention implementing a structured clinical pathway consisting of risk detection, assessment and triage, and follow-up with transitional care. METHODS: A stepped wedge cluster randomized design will evaluate the effectiveness of STARRS-PC compared to treatment as usual (TAU) across 16 primary care sites. 2324 adolescents aged 12-17 screening positive for suicide risk will be enrolled (1033 in the TAU phase; 1291 in the intervention phase). Primary outcomes include suicide attempts and deaths. Secondary outcomes are suicidal ideation, non-suicidal self-injury, and family satisfaction. Youth and parents will complete assessments at baseline, 3, 6, and 12 months. Tests of moderation and mediation will be conducted to understand finding generalizability and identify variables that change as a result of the intervention and are associated with suicide attempts/death. Implementation outcomes (reach, adoption, maintenance, feasibility, and acceptability) will be evaluated through provider surveys and qualitative interviews. CONCLUSIONS: This study will provide evidence on the effectiveness and implementation of a quality improvement supported, structured suicide prevention pathway in pediatric primary care, which could transform youth suicide risk identification and management.
Addressing social needs to improve health in adults with multiple chronic conditions: A comparative effectiveness trial of two real-world social needs interventions.
Tucher EL, Steele AL, Uratsu CS … +6 more , Hamilton LK, Brown MC, Nugent JR, Jones DH, Gottlieb LM, Grant RW
Contemp Clin Trials · 2026 Feb · PMID 41453516 · Publisher ↗
BACKGROUND: Adults with multiple chronic conditions (MCC, defined as two plus chronic conditions) account for one-third of the United States population but 71 % of healthcare expenditures. Many adults with MCC also manag...
BACKGROUND: Adults with multiple chronic conditions (MCC, defined as two plus chronic conditions) account for one-third of the United States population but 71 % of healthcare expenditures. Many adults with MCC also manage social needs like food insecurity or housing instability, which are associated with worse disease outcomes and decreased life expectancy. Research on social needs interventions demonstrated that targeted interventions can significantly improve care utilization and patient well-being. However, many published trials evaluating social needs navigation or resource referrals have focused on a single social need, specific health conditions, or a single intervention strategy. METHODS: This trial ("Addressing Social Needs to Improve Health in Adults with Multiple Chronic Conditions") is a comparative-effectiveness randomized control trial (CE-RCT) comparing the clinical impact of two commonly implemented social needs interventions ("higher intensity" social needs phone navigation versus "lower intensity" automated electronic resource outreach). It will enroll 12,000 adults with MCC, one or more evidence-based clinical care gaps, and one or more social needs within Kaiser Permanente, an integrated delivery system serving over 12.5 million members. Participants can be randomized to a higher or lower intensity intervention. The primary outcomes are 12-month clinical care gap closures measured via electronic health records, and 6-month receipt of social services and reductions in social needs, measured via patient surveys. Secondary outcomes include survey and interview assessments of stress and experiences of social care. CONCLUSION: Results from this CE-RCT provide policy and practice-relevant evidence comparing the impacts of different approaches to addressing social needs in patients with MCC. TRIAL REGISTRATION: clinicaltrials.gov/study/NCT06941519.
iMprovIng the meNtal hEalth of home healTh AiDeS: A study protocol for the MINDSET study.
Sterling MR, Shum M, Peramsetty R … +14 more , Aucapina J, Wiggins F, Colon C, Ringel JB, Avgar AC, Dell N, Habib BN, Banerjee S, Tsui E, Andreae SJ, Kozlov E, Landis C, Solano-Kamaiko IR, Safford MM
Contemp Clin Trials · 2026 Feb · PMID 41435914 · Publisher ↗
Home health aides and attendants (HHAs) are a fast-growing healthcare workforce who are integral to the rising movement that allows older adults to age in place. However, HHAs themselves are a vulnerable group of caregiv...
Home health aides and attendants (HHAs) are a fast-growing healthcare workforce who are integral to the rising movement that allows older adults to age in place. However, HHAs themselves are a vulnerable group of caregivers. Mostly middle-aged women of color paid dismally low wages, HHAs' work is physically taxing, emotionally challenging, and socially isolating. Consequently, HHAs have high levels of depressive symptoms and stress. Prior studies suggest that HHAs want to address this, but do not know how and cannot access or afford traditional mental health services. Here we describe the protocol for a pilot randomized control trial (RCT) that aims to improve the mental health of HHAs through peer coaching (PC), an established and effective behavioral health intervention which has never been applied to HHAs or their workplace, the home environment. In collaboration with a labor and management fund of the largest healthcare union in the US (1199SEIU), we will conduct a single-site parallel arm pilot RCT with 100 HHAs to evaluate the feasibility, acceptability, and effectiveness of an adapted Living Healthy Program for HHAs delivered by PCs (intervention arm) vs. a general health promotion program (attention control arm). Primary effectiveness outcome will be a reduction in depressive symptoms; secondary effectiveness outcomes will be a reduction in stress and loneliness. This study offers a novel and potentially scalable way to improve the health of HHAs, an often overlooked, undervalued, but increasingly vital workforce that is needed to care for our rapidly aging population.
The Pharmaceutically Enhanced Reinforcement for Reduced Alcohol and Smoking (PERRAS) Study: Protocol for a randomized clinical trial.
Palombo P, Akana N, Bowen A … +13 more , Schmidt A, Ryan R, Hovland S, Stark BC, Rodin N, Chaytor N, McDonell MG, Burduli E, Layton M, Roll JM, Smith CL, Miguel AQ, McPherson SM
Contemp Clin Trials · 2026 Feb · PMID 41422851 · Publisher ↗
BACKGROUND: Alcohol and tobacco are often used together, and their co-use is directly associated with a high incidence of morbidity and mortality. While there are currently no guidelines for treating co-addiction to alco...
BACKGROUND: Alcohol and tobacco are often used together, and their co-use is directly associated with a high incidence of morbidity and mortality. While there are currently no guidelines for treating co-addiction to alcohol and tobacco, studies suggest that integrated approaches may effectively reduce the use of both substances. Grounded in the Addiction Neuroclinical Assessment (ANA) framework, this study aims to evaluate the effectiveness of combining Contingency Management (CM) for Alcohol Use Disorder (AUD) with Varenicline for smoking cessation to significantly reduce alcohol and tobacco use among individuals with an AUD who smoke and are seeking treatment. In addition, the study will evaluate the mediator effect of the ANA domains, systematically measured and evaluated to determine their role in treatment outcomes. METHODS: Study will take place in Spokane-WA. After a two-week induction period, a total of 205 eligible participants will be randomized into one of two 12-week treatment conditions in equal proportions: CM + varenicline (experimental condition) and Non-Contingent (NC) + varenicline (control condition). Participants in the CM + varenicline group will receive rewards contingent on the submission of negative alcohol samples, while the NC + varenicline group will receive rewards for submitting urine samples, independent of alcohol positivity. Primary outcomes include objective verification of abstinence during the 12-week intervention phase (measured thrice-weekly). Follow-up evaluations will be conducted during the first, third, and sixth months. CONCLUSIONS: If demonstrated to be efficacious, this treatment approach has the potential to produce important health benefits for a highly prevalent population in desperate need for an integrated treatment. It may also assist in identifying how different ANA-based responses impact treatment outcomes.
Virtual Intervention for Binge Eating (VIBE): Study protocol for a user-informed mobile intervention for dysregulated eating and weight gain prevention in adolescents.
Goldschmidt AB, Ortega A, Rooper IR … +9 more , Obleada KT, Chapa DAN, Silverberg B, Stalvey E, Camino MK, Levine MD, Yu L, Eichen DM, Graham AK
Contemp Clin Trials · 2026 Feb · PMID 41421758 · Full text
BACKGROUND: Pediatric overweight and obesity continue to be major public health issues. Loss of control (LOC) eating and overeating are two obesity-related phenotypes affecting approximately 30 % of adolescents with over...
BACKGROUND: Pediatric overweight and obesity continue to be major public health issues. Loss of control (LOC) eating and overeating are two obesity-related phenotypes affecting approximately 30 % of adolescents with overweight/obesity that may undermine weight control treatment outcome. Cognitive-behavioral therapy (CBT) has promising effects on dysregulated eating, but effects on weight are modest, access is limited, and developmental changes in self-regulation (which may limit implementation of treatment skills) are often ignored. METHODS: In the current proposal, we will apply human-centered design methods to design and test a novel CBT-based digital intervention, augmented with content and features to improve self-regulation, for weight gain prevention and dysregulated eating in adolescents. The first phase will involve design activities with adolescents (n = 25-30) who have body mass index (BMI; kg/m) ≥ 75th percentile for age and sex and report dysregulated eating, to understand desired presentation, features, and barriers/facilitators to engagement. Research activities will include a needs assessment and iterative prototyping, usability testing, and refinement of the digital intervention. The second phase will be a multisite single arm open trial involving 50 adolescents who have or are at risk for overweight/obesity and report LOC and/or overeating to investigate intervention feasibility and preliminary efficacy, as well as putative treatment mechanisms and targets. CONCLUSIONS: Results of the study will inform the design of an adequately powered randomized controlled trial. The project has clear potential to significantly impact public health via development of a relevant, accessible, and scalable intervention for adolescents at risk for adverse physical and mental health outcomes. CLINICAL TRIAL REGISTRATION NUMBER: NCT06819813.
Geographic location and clinical trial knowledge, invitation, and participation among adults in the United States.
Onyeaka HK, Mate-Kole MN, Acheampong IA … +7 more , Arthur A, Song MT, Akhiwu TO, Mensah D, Ozoalor C, Chido-Amajuoyi OG, Amonoo HL
Contemp Clin Trials · 2026 Feb · PMID 41421757 · Publisher ↗
BACKGROUND/AIMS: Clinical trials are essential to evaluating novel treatments and improving disease-related outcomes through innovative therapies. Despite underrepresentation of rural communities in clinical trial outrea...
BACKGROUND/AIMS: Clinical trials are essential to evaluating novel treatments and improving disease-related outcomes through innovative therapies. Despite underrepresentation of rural communities in clinical trial outreach and participation, geographic disparities in clinical trials have been minimally explored. We examined clinical trial knowledge, invitation, and participation among participants in urban and rural geographic locations in the United States. METHODS: We conducted cross-sectional data analysis on self-reported data from Health Information National Trends Survey (HINTS) 5 Cycle 4. Population-level estimates were obtained using jack-knife replicate weights. RESULTS: Geographic location was not associated with clinical trial knowledge, invitation, and participation. However, the relatively low absolute invitation rates across urban and rural populations may suggest that substantial gaps in recruitment persist universally, regardless of geographic location in the United States. CONCLUSIONS: In this nationally representative study, we found no statistically significant differences in clinical trial knowledge, invitation or participation by geographical location in the United States. Our findings suggest that geographic residence may not be a primary barrier to clinical trial engagement once sociodemographic differences are accounted for. Targeted efforts to improve awareness and reduce structural barriers, along with continued investment in equitable recruitment strategies, will be important to ensuring that clinical trials reflect the diversity of the populations they aim to serve.
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